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    Home > Medical News > Medical World News > The State Administration of municipal supervision issues a document that these machinery enterprises will be punished

    The State Administration of municipal supervision issues a document that these machinery enterprises will be punished

    • Last Update: 2019-12-31
    • Source: Internet
    • Author: User
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    Recently, the state municipal bureau of Supervision issued the Interim Measures for the administration of advertisement examination of drugs, medical devices, health food and formula food for special medical purposes (hereinafter referred to as the Interim Measures), with the full text attached at the end of the article According to the interim measures, some illegal enterprises will be fined, and at the same time, they will make clear regulations on advertising According to the interim measures, those who publish device advertisements in violation of the relevant provisions of these measures, as stipulated in the advertising law of the people's Republic of China and other laws and regulations, shall be punished in accordance with the relevant provisions, and the responsible advertisers, advertising agents and advertisement publishers shall be fined not more than three times of the illegal gains, but not more than 30000 yuan; those who have no illegal gains shall be fined 10000 yuan The following penalties The market supervision and administration departments and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the central government shall be responsible for the examination of advertisements of drugs, medical devices, health food and formula food for special medical purposes, and may entrust other administrative organs to carry out the examination of advertisements in accordance with law According to the interim measures, medical devices and other advertisements shall be true and lawful, and shall not contain false or misleading contents Advertisers shall be responsible for the authenticity and legality of medical devices and other advertisements, and shall not publish relevant advertisements without examination Advertisements for medical devices must include the following situations: (1) To use or disguise the names or images of state organs, state functionaries, military units or military personnel, or to use military equipment and facilities for advertising; (2) Use the names or images of scientific research institutions, academic institutions, trade associations or experts, scholars, doctors, pharmacists, clinical nutritionists, patients, etc for recommendation and certification; (3) Violate scientific laws, express or imply that all diseases can be treated, all symptoms can be adapted, all people can be adapted, or normal life and disease treatment are necessary; (4) Cause the public to have unnecessary worries and fears about their health and diseases, or make the public misunderstand the content that the product will suffer from a certain disease or aggravate the disease if not used; (5) It contains "safety", "safety, non-toxic and side effects" and "little side effects" It indicates or implies that the ingredients are "natural", so the safety is guaranteed; (6) It contains "hot sale, rush purchase, trial", "necessary for family, free treatment, free gift" and other inductive contents, "evaluation, sorting, recommendation, designation, selection, award" and other comprehensive evaluation contents, "invalid refund, insurance company insurance" and other guarantee contents, and encourages consumers to use drugs, health food and formula food for special medical purposes arbitrarily or excessively Content; (7) It includes the name, address, contact information, diagnosis and treatment items, diagnosis and treatment methods of the medical institution, as well as the contents of medical services such as free diagnosis, medical consultation telephone number, special outpatient service, etc; (8) Other contents not allowed by laws and administrative regulations Interim Measures for the administration of advertisement examination of drugs, medical devices, health food and formula food for special medical purposes (promulgated by order No 21 of the State Administration of market supervision on December 24, 2019) Article 1 These measures are formulated in accordance with the advertising law of the people's Republic of China and other laws and administrative laws and regulations for the purpose of strengthening the supervision and administration of advertisements of drugs, medical devices, health food and formula food for special medical purposes, standardizing the examination of advertisements, maintaining the order of advertisement market and protecting the legitimate rights and interests of consumers Article 2 These Measures shall apply to the examination of advertisements of drugs, medical devices, health food and formula food for special medical purposes Without examination, advertisements for drugs, medical devices, health food and formula food for special medical purposes shall not be published Article 3 advertisements of drugs, medical devices, health food and formula food for special medical purposes shall be true and lawful, and shall not contain false or misleading contents The Advertiser shall be responsible for the authenticity and legality of the advertising contents of drugs, medical devices, health food and formula food for special medical purposes Article 4 the State Administration of market supervision and administration shall be responsible for organizing and guiding the examination of advertisements of drugs, medical devices, health food and formula food for special medical purposes The market supervision and administration departments and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as the advertising examination authorities) shall be responsible for the examination of advertisements of drugs, medical devices, health food and formula food for special medical purposes, and may entrust other administrative organs to carry out the examination of advertisements in accordance with law Article 5 the contents of drug advertisements shall be subject to the instructions approved by the drug regulatory department under the State Council Where the advertisement of a drug involves the name, indications, functions, pharmacological effects, etc of the drug, it shall not exceed the scope of the instructions Drug advertisements shall be marked with taboos and adverse reactions, prescription drug advertisements shall also be marked with "this advertisement is only for medical and pharmaceutical professionals to read", over-the-counter drug advertisements shall also be marked with OTC and "please purchase and use according to the drug instructions or under the guidance of pharmacists" Article 6 the contents of the medical device advertisement shall be subject to the registration certificate or filing certificate approved by the drug regulatory department, and the contents of the registered or filed product manual If the medical device advertisement involves the name, scope of application, mechanism, structure and composition of the medical device, it shall not exceed the scope of the registration certificate or filing certificate, registered or filed product manual The advertisement of medical devices recommended for personal use shall be marked with "please read the product manual carefully or purchase and use under the guidance of medical personnel" If there are taboo contents and precautions in the medical device product registration certificate, the advertisement shall clearly indicate "see the instruction for details of taboo contents or precautions" Article 7 the contents of health food advertisements shall be subject to the registration certificate or filing certificate approved by the market supervision and administration department, and the contents of the registered or filed product instructions, and shall not involve the functions of disease prevention and treatment If the health food advertisement involves health care function, functional ingredients or symbolic ingredients and contents of the product, suitable population or consumption, etc., it shall not exceed the scope of the registration certificate or filing certificate, registration or filing product manual The advertisement of health food shall clearly indicate that "health food is not a drug and cannot replace drugs to treat diseases", state that this product cannot replace drugs, and clearly indicate the health food logo, suitable people and unsuitable people Article 8 the contents of the advertisement of formula food for special medical purposes shall be subject to the registration certificate, product label and specification approved by the State Administration of market supervision and administration If the advertisement of formula food for special medical purposes involves the product name, formula, nutritional characteristics, applicable population, etc., it shall not exceed the scope of registration certificate, product label and instruction manual The advertisement of formula food for special medical use shall clearly indicate the applicable population, "not applicable to non target population" and "please use under the guidance of doctor or clinical nutritionist" Article 9 the advertisement of drugs, medical devices, health food and formula food for special medical purposes shall be marked with the approval number of the advertisement Article 10 the contents that should be prominently indicated in advertisements of drugs, medical devices, health food and formula food for special medical purposes must be clearly visible and easy to identify in font and color, and shall be continuously displayed in video advertisements Article 11 advertisements for drugs, medical devices, health food and formula food for special medical purposes shall not violate the provisions of Articles 9, 16, 17, 18 and 19 of the advertising law of the people's Republic of China, and shall not include the following situations: (1) To use or disguise the names or images of state organs, state functionaries, military units or military personnel, or to use military equipment and facilities for advertising; (2) Use the names or images of scientific research institutions, academic institutions, trade associations or experts, scholars, doctors, pharmacists, clinical nutritionists, patients, etc for recommendation and certification; (3) Violate scientific laws, express or imply that all diseases can be treated, all symptoms can be adapted, all people can be adapted, or normal life and disease treatment are necessary; (4) Cause the public to have unnecessary worries and fears about their health and diseases, or make the public misunderstand the content that the product will suffer from a certain disease or aggravate the disease if not used; (5) It contains "safety", "safety, non-toxic and side effects" and "little side effects" It indicates or implies that the ingredients are "natural", so the safety is guaranteed; (6) It contains "hot sale, rush purchase, trial", "necessary for family, free treatment, free gift" and other inductive contents, "evaluation, sorting, recommendation, designation, selection, award" and other comprehensive evaluation contents, "invalid refund, insurance company insurance" and other guarantee contents, and encourages consumers to use drugs, health food and formula food for special medical purposes arbitrarily or excessively Content; (7) It includes the name, address, contact information, diagnosis and treatment items, diagnosis and treatment methods of the medical institution, as well as the contents of medical services such as free diagnosis, medical consultation telephone number, special outpatient service, etc; (8) Other contents not allowed by laws and administrative regulations Article 12 the holder of the registration certificate or filing certificate of drugs, medical devices, health food and formula food for special medical purposes and the production and marketing enterprise authorized by him shall be the advertisement applicant (hereinafter referred to as the applicant) The applicant may entrust an agent to handle the application for advertising examination of drugs, medical devices, health food and formula food for special medical purposes Article 13 an application for the examination of advertisements of pharmaceuticals and formula foods for special medical purposes shall be submitted to the local advertisement examination organ where the advertiser is located, such as the manufacturer or the import agent, according to law The application for examination of advertisements of medical devices and health food shall be submitted to the advertisement examination organ of the place where the manufacturer or import agent is located according to law Article 14 when applying for the examination of advertisements of drugs, medical devices, health food and formula food for special medical purposes, the applicant shall submit the examination form of advertisements, samples of advertisements consistent with the contents published, and the following legal and effective materials: (1) Materials related to the subject qualification of the applicant, or legal and effective registration documents; (2) Product registration certificate or filing certificate, registered or filed product labels and instructions, and production license documents; (3) Relevant valid certification materials of intellectual property rights involved in the advertisement For the production and business operation enterprises that are authorized to accept the application as applicants, they shall also submit legal authorization documents; for those who entrust agents to apply, they shall also submit power of attorney and relevant materials of agent's subject qualification Article 15 An applicant may apply at the acceptance window of the advertising examination authority, or submit an application for advertisement of drugs, medical devices, health food and formula food for special medical purposes through letters, faxes, e-mails or e-government platforms After receiving the application submitted by the applicant, the advertising examination organ shall make a decision of acceptance or rejection within five working days If the application materials are complete and conform to the legal form, it shall be accepted
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